Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza A Virus, H1N1 Subtype

Keywords

pkhealthy subjectsinfluenza virusSafetypandemic

Outcome Measures

Primary Outcomes (1)

Safety and Tolerability: AEs, Labs, Vitals
Nineteen days

Secondary Outcomes (1)

Pharmacokinetic parameters per protocol
Five days

Study Arms (1)

Period

EXPERIMENTAL

10 mg BID Zanamivir or placebo for 5 days

Drug: Zanamivir

Interventions

ZanamivirDrug

Rotahaler placebo 10mg BID 5 days

Period

ZanamivirDrug

Rotahaler Zanamivir 10mg BID 5 days

Period

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

The subject is healthy as judged by a responsible physician with no clinically significant abnormality identified on a medical evaluation
Male and female volunteers from 18-55 years of age, inclusively, at the time of signing the informed consent.

Sponsors & Collaborators

GlaxoSmithKline
Industrylead

Study Sites (1)

GSK Investigational Site

Minneapolis, Minnesota, 55404, United States

Related Publications (1)

Weller S, Jones LS, Lou Y, Piscitelli S, Peppercorn A, Ng-Cashin J. Safety, tolerability and pharmacokinetics of orally inhaled zanamivir: a randomized study comparing Rotacap/Rotahaler and Rotadisk/Diskhaler in healthy adults. Antivir Ther. 2013;18(6):827-30. doi: 10.3851/IMP2631. Epub 2013 May 21.
PMID: 23696221BACKGROUND

MeSH Terms

Interventions

Zanamivir

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsSialic AcidsNeuraminic AcidsSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmino SugarsCarbohydrates

Study Officials

GSK Clinical Trials
GlaxoSmithKline
STUDY DIRECTOR

Enrollment

18 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 24, 2009

First Posted

October 5, 2009

Study Start

October 12, 2009

Actual (reported)

You may not qualify if:

The subject has a positive pre-study urine drug/ alcohol screen.
Significant pulmonary disease, such as chronic obstructive pulmonary disease, asthma, or other pulmonary diseases that may affect the pulmonary disposition of study drug or pose a safety risk for oral inhaled study drug.
Subjects with symptoms of upper respiratory infections at study entry.
Subjects currently presenting with chronic upper or lower respiratory tract infection, allergic rhinitis, hay fever, or sinusitis.
Significant psychiatric disease, such as anxiety disorders or psychotic disorders.
A creatinine clearance less than 70mL/min
History of regular alcohol consumption within 6 months of the study as defined in the protocol
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
Exposure to more than four experimental medications within 12 months prior to the first dosing day.
Ingestion of alcohol, grapefruit juice or grapefruit products, caffeine-containing food or beverage with 48 hours prior to the first dose of study medication and continuing through study completion.
Subjects who have donated blood to the extent where participation in the study would result in excess of 500mL blood donated within a 56 day period.
History of sensitivity to any of the study medications, or components thereof (including lactose) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. In addition, if heparin is used during pharmacokinetic sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
Lack of suitability for participation in this study, for any reason, in the opinion of the investigator.
+2 more criteria

Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Period

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Available IPD Datasets

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Period

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Available IPD Datasets

Source record

Locations